DSP-1083 for Parkinson's Disease

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sumitomo Pharma America, Inc.

Must be taking: L-DOPA, L-DOPA enhancers

Disqualifiers: Under 40, Over 70, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

23 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of a new treatment called DSP-1083 for individuals with Parkinson's disease. Participants will either receive the DSP-1083 implant or undergo a sham surgery, which mimics the procedure without delivering the treatment, to compare outcomes. The trial seeks individuals who have had Parkinson's for over 5 years and struggle to control symptoms despite medication. This offers a chance to explore new treatment options when current medications are insufficient. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should have been on an optimized oral antiparkinsonian medication regimen for at least 3 months, including L-DOPA and another medication that increases its effects.

Is there any evidence suggesting that DSP-1083 is likely to be safe for humans?

Research shows that DSP-1083, a treatment under study for Parkinson's disease, is in the early stages of human testing. Detailed safety information is not yet available. However, these early trials are crucial for understanding how well participants can tolerate the treatment.

As a Phase 1 trial, the primary focus is on safety and tolerance. Researchers closely monitor for any side effects and the body's response. Phase 1 trials typically involve a small number of participants to minimize risk while collecting essential data.

If DSP-1083 proves well-tolerated in this phase, it could lead to further studies with more participants. Currently, joining the trial contributes to the initial steps in assessing the safety of DSP-1083 for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

DSP-1083 is unique because it involves the implantation of live cells directly into the brain, offering a novel approach for treating Parkinson's disease. Unlike current treatments like levodopa or dopamine agonists that primarily manage symptoms by boosting dopamine levels, DSP-1083 aims to potentially modify the disease by providing a direct cellular therapy. Researchers are excited because this could lead to longer-lasting improvements and potentially slow the progression of Parkinson's, which existing medications can't achieve.

What evidence suggests that DSP-1083 might be an effective treatment for Parkinson's Disease?

Research has shown that DSP-1083 could be a promising treatment for Parkinson's Disease. This trial will evaluate DSP-1083, which uses dopamine neural progenitor cells. These cells aim to replace the dopamine-producing cells lost in the brains of people with Parkinson's. Early results suggest that replacing these cells might improve symptoms by restoring dopamine levels. Although few studies have been conducted on humans, the approach is based on a solid scientific understanding of how Parkinson's affects the brain. The hope is that by directly addressing the loss of dopamine, DSP-1083 will help manage and reduce symptoms of Parkinson's Disease. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for men and women with Parkinson's Disease, specifically those who may also have dementia. Participants should be eligible to undergo a surgical procedure. The study excludes individuals based on certain medical conditions or treatments that could interfere with the trial.

Inclusion Criteria

Subject is approved by the Sponsor Eligibility Committee following review of all required information collected during Screening and prior to surgery on Day -1

My Parkinson's symptoms improve by at least 30% with L-DOPA, without other Parkinson's meds.

I am between 40 and 69 years old and have been diagnosed with Parkinson's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Cohort 1 will receive 2 unilateral surgical procedures separated by approximately 28 weeks. Cohorts SS2 and SS3 will undergo bilateral implantation of DSP-1083 in a single surgical procedure.

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neuroimaging and cognitive assessments.

104 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DSP-1083

Trial Overview The study is testing the effects of implanting a device called DSP-1083 in patients with Parkinson's Disease compared to a sham (fake) surgery. It aims to assess how safe and tolerable this treatment is, as well as its potential benefits.

How Is the Trial Designed?

Group I: DSP-1083 Experimental Treatment 1 Intervention

Implantation of DSP-1083 (2.7M viable cells per hemisphere; 5.4M total cell dose)

Group II: Sham Surgery Placebo Group 1 Intervention

Sham surgery subjects will undergo a partial thickness burr hole surgical procedure on each side of the skull with no DSP-1083 administration.

Who Is Running the Clinical Trial?

Sumitomo Pharma America, Inc.

Lead Sponsor

Trials

244

Recruited

51,500+

Jatin Shah

Sumitomo Pharma America, Inc.

Chief Medical Officer since 2024

MD from an unspecified institution

Tsutomu Nakagawa

Sumitomo Pharma America, Inc.

Chief Executive Officer since 2024

MBA from Waseda University

Published Research Related to This Trial

IRL790, a new treatment targeting the dopamine D3 receptor, was found to be safe and well-tolerated in a 4-week randomized controlled trial involving 15 Parkinson's disease patients with levodopa-induced dyskinesia, with no serious adverse events reported.

While the study showed a numeric reduction in dyskinesia symptoms, further research is needed to confirm its efficacy, and the findings will help shape future phase 2 studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of IRL790 in Parkinson's disease with levodopa-induced dyskinesia-a phase 1b trial. Svenningsson, P., Johansson, A., Nyholm, D., et al.[2020]

Safinamide significantly improves the duration of 'On-time' without dyskinesia in Parkinson's disease patients compared to a control group, with better outcomes observed at both 50 mg and 100 mg doses.

The treatment also leads to greater improvements in the Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) scores, indicating enhanced motor function, while showing no significant difference in adverse events between safinamide and control groups, suggesting it is a safe option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of the effectiveness and safety of safinamide for levodopa-induced motor complications in Parkinson's disease. Li, J., Zhang, J., Meng, P.[2023]

In a study involving squirrel monkeys, the D3 receptor partial agonist BP897 was found to significantly reduce L-dopa-induced dyskinesias (LIDs), but this reduction came at the cost of diminishing the antiparkinsonian effects of L-dopa.

Unlike previous findings in macaques, BP897 did not maintain the therapeutic benefits of L-dopa while reducing dyskinesias in squirrel monkeys, suggesting that its effectiveness for treating LIDs in Parkinson's disease may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the D3 dopamine receptor partial agonist BP897 [N-[4-(4-(2-methoxyphenyl)piperazinyl)butyl]-2-naphthamide] on L-3,4-dihydroxyphenylalanine-induced dyskinesias and parkinsonism in squirrel monkeys. Hsu, A., Togasaki, DM., Bezard, E., et al.[2017]

A panel of D3 dopamine receptor selective compounds, particularly WC 10, showed promise in reducing L-dopa-associated abnormal involuntary movements (AIMs) in a rat model of Parkinson's Disease, indicating their potential as therapeutic agents for L-dopa-induced dyskinesia.

The efficacy of these D3 receptor compounds was enhanced when administered alongside L-dopa, and notably, the D3 receptor agonist WC 44 did not induce abnormal involuntary movements, suggesting a safer profile compared to other dopamine receptor agonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of D2 and D3 dopamine receptor selective compounds on L-dopa-dependent abnormal involuntary movements in rats. Kumar, R., Riddle, LR., Griffin, SA., et al.[2021]

5-HT3 antagonists like ondansetron and granisetron can reduce l-DOPA induced dyskinesia in animal models without affecting the drug's ability to alleviate Parkinson's symptoms, suggesting a potential therapeutic strategy for managing side effects of l-DOPA.

Increased binding of the 5-HT3 receptor in specific brain regions of hemi-parkinsonian rats correlates with the severity of abnormal involuntary movements, indicating that changes in 5-HT3 neurotransmission may play a role in the development of dyskinesia associated with l-DOPA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autoradiographic labelling of 5-HT3 receptors in the hemi-parkinsonian rat brain. Kwan, C., Lévesque, C., Bédard, D., et al.[2022]

The D3 dopamine receptor antagonist PG01037 showed potential in reducing L-dopa-associated abnormal involuntary movements (AIMs) in a rat model of Parkinson's Disease, particularly when administered intraperitoneally shortly after L-dopa treatment.

PG01037 did not negatively impact motor coordination or significantly reduce the beneficial effects of L-dopa, suggesting it could be a safe and effective option for managing dyskinesia in patients with Parkinson's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the D3 dopamine receptor selective antagonist PG01037 on L-dopa-dependent abnormal involuntary movements in rats. Kumar, R., Riddle, L., Griffin, SA., et al.[2021]

Sarizotan at a dose of 2 mg/day is considered safe for Parkinson's disease patients with dyskinesia, showing significant improvement in the composite score of UPDRS Items 32+33, which measures dyskinesia duration and disability.

The study, which included 398 participants, found no significant changes in diary-based measures of dyskinesia or the AIMS score compared to placebo, indicating that while sarizotan may have some benefits, further research is needed to confirm its efficacy in reducing dyskinesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sarizotan as a treatment for dyskinesias in Parkinson's disease: a double-blind placebo-controlled trial. Goetz, CG., Damier, P., Hicking, C., et al.[2012]

In a 13-week randomized controlled trial involving 75 Parkinson's disease patients, ADS-5102 (amantadine) significantly reduced levodopa-induced dyskinesia, showing a mean improvement of -20.7 on the Unified Dyskinesia Rating Scale compared to -6.3 for placebo (P < .0001).

ADS-5102 also decreased 'OFF' time by 1.1 hours, indicating better control of Parkinson's symptoms, although it was associated with some adverse effects like dry mouth and nausea, leading to a higher discontinuation rate compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, placebo-controlled trial of ADS-5102 (amantadine) extended-release capsules for levodopa-induced dyskinesia in Parkinson's disease (EASE LID 3). Oertel, W., Eggert, K., Pahwa, R., et al.[2022]

SK609, a selective dopamine D3 receptor agonist, significantly improved motor function in a rodent model of Parkinson's disease without causing abnormal involuntary movements (AIMs), which are common side effects of traditional l-dopa therapy.

When used alongside l-dopa, SK609 reduced the AIMs typically induced by l-dopa, suggesting it could enhance treatment for Parkinson's disease while minimizing negative side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo characterization of a novel dopamine D3 receptor agonist to treat motor symptoms of Parkinson's disease. Simms, SL., Huettner, DP., Kortagere, S.[2015]

Citations

1. sumitomo-pharma.com sumitomo-pharma.com/news/20240328.html

Initiation of Company-sponsored Clinical Study on iPS Cell ... Parkinson's disease is a progressive neurodegenerative disease that is thought to be caused by a marked decrease in striatal dopamine levels due ...

2. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/dsp-1083-sumitomo-pharma-parkinson-s-disease-likelihood-of-approval/

DSP-1083 by Sumitomo Pharma for Parkinson's Disease According to GlobalData, Phase II drugs for Parkinson's Disease have a 41% phase transition success rate (PTSR) indication benchmark for ...

3. withpower.com withpower.com/trial/dsp-1083-for-parkinsons-disease-57145

DSP-1083 for Parkinson's Disease Safinamide significantly improves the duration of 'On-time' without dyskinesia in Parkinson's disease patients compared to a control group, with better outcomes ...

4. braintrials.substack.com braintrials.substack.com/p/dopaminergic-cell-therapies-for-parkinson

Dopaminergic Cell Therapies for Parkinson Disease In this post, I'll explore the current dopaminergic cell therapies in the pipeline, review the available clinical trial data, and address the ...

5. delveinsight.com delveinsight.com/blog/5-emerging-cell-and-gene-therapies-for-parkinsons-disease

5 Promising Cell and Gene Therapies for Parkinson's ... DSP-1083 is currently in the Phase I/II stage of development for the treatment of Parkinson's disease. It consists of dopamine neural progenitor ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/589656

A Multicenter Study to Evaluate Safety, Tolerability, and ... The goal of this study is to evaluate the safety, tolerability, and clinical responses following implantation of DSP-1083.